January-February 2011 Update

I n this column, I would like to make the readership aware of a number of important updates. The first two have to do with the Johnson and Johnson (J&J) product, Concerta^®. In November of 2010, J&J received approval from the U. S. Food and Drug Administration (FDA) for labeling changes. The change seemingly eliminates the previously established section on Drug Interactions (section 7.4) as it related to the product's concomitant use with clonidine. The older labeling section explained that serious adverse events had been reported with the co-administration of both types of agents, despite the fact that a direct causal model had not been established. The second update occurred on November 2, 2010, when J&J announced it entered into an agreement with Watson Laboratories, Inc., to distribute a generic version of Concerta^®. The launch is slated for May 2011.

Another important update that readers should take note of is that in November 2010 Bristol Myers Squib received approval from the FDA to change its labeling of Buspar^® (buspirone hydrochloride). The change will be included in the Drug/Laboratory Test Interactions Section. It will explain that buspirone may potentially interfere with the urinary catecholamine readings of metanephrine, during assay level determination for pheochromocytomas. As readers may recall, pheochromocytomas are tumors originating in the chromaffin cells of the medulla of the adrenal glands, which produce exaggerated levels of chatecholamines. Apparently, the presence of buspirone interferes with readings of metanephrine levels (the metabolic by product of epinephrine) when testing for pheochromocytomas, resulting in a false positive laboratory result. It is cautioned that buspirone should be discontinued at least 48 hours before obtaining urine samples for this condition.

The last update marks the approval of another antipsychotic agent that will be launched in February 2011. In October 2010, Sunovion Pharmaceuticals Inc., the U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd., announced that the FDA approved lurasidone hydrochloride, brand named as Latuda^® for the treatment of schizophrenia. Latuda is a once-daily, oral atypical antipsychotic. Upon its launch I will provide the readership with further details of the product.

I would like to make the readers aware of an article that raises a most interesting question and highlights a controversial aspect of our field, in general. In many areas of medicine, the goal is to integrate findings across organ systems into a singular illness, thus the phenomena of clumping versus splitting. However, in psychiatry we are often prompted to parcel findings into numerous individual illnesses or entities. Seemingly, the presence or absence of a behavioral defined illness, autism, in individuals with the heritable Fragile X syndrome may be a fertile realm to highlight our dilemma. Hall et al. (2010) recently tackled this issue by examining the overlap of autistic symptoms in a group 120 patients who had been diagnosed with Fragile X syndrome. Patient's ages ranged from 5 to 25 years old. They were assessed with the Autism Diagnostic Observation Schedule (ADOS) and the Social Communication Questionnaire (SCQ). Of the 70 patients assessed with the ADOS, 51.4% of males and 21.2% of females scored within the “autism category.” As the authors explained there is a problem in “applying dichotomus phenomenologically defined diagnoses to symptoms and behaviors that may exist as continuous variables.” (pg.928). Clearly, the issue is complex.

An updated list of conferences follows for your consideration.